其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution (midazolam hydrochloride) (batch number: 620903600) has missing information regarding having to break the seal on the inner container before use. All other sections of the PIL are unaffected.
Healthcare professionals are advised to inform patients that there is an error in the PIL. The information regarding breaking the seal on the inner container before use should be followed.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-buccolam-10mg-oromucosal-solution-el-23-a-slash-18
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, May 23, 2023
Issued at HKT 14:00
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